Wake-Up Call: FDA Pushes Drugmakers To Weaken Sleeping Pills

The Food and Drug Administration announced Thursday that it was requiring companies that make Ambien and similar sleeping pills to sharply cut the doses of the drugs.

The agency says it is taking the step for the brands Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien, because tests showed the active ingredient in the medications, zolpidem, stays in the body longer than had been thought. That raises the possibility that people taking the drugs will remain drowsy the next day, making activities such as driving and operating heavy machinery dangerous.

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe and patients should take the lowest dose capable of treating the patient’s insomnia,” Ellis Unger, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.